Thursday, October 31, 2013

Non-publication of clinical trial results was common and the availability of results in in a government-funded database was limited, with higher non-publication rates among industry-funded trials, an analysis found.

To estimate the frequency with which results of large randomized clinical trials registered with ClinicalTrials.gov are not available to the public, researchers conducted a cross sectional analysis of trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to January 2009. The final literature search occurred in November 2012.

Of 585 registered trials, 171 (29%) remained unpublished. Among trials with a completion date listed in ClinicalTrials.gov (n=542) and that had been published (389/542, 72%), the median time from study completion to publication was 27 months (interquartile range 20-37 months).

Of the 171 trials that remained unpublished, 38 (22%) had results available on ClinicalTrials.gov. Among all 585 trials, 414 (71%) had published results, 38 (6%) were unpublished but had results available on ClinicalTrials.gov, and 133 (23%) had no results available either in either medium.

Fifteen (39%) of the 38 trials with results reported also provided statistical analyses for at least 1 primary outcome. Nine of these 15 (60%) reported statistically significant results clearly favoring the intervention, whereas another four (27%) reported meeting a standard of non-inferiority. The other 23 trials that were unpublished but had results available on ClinicalTrials.gov reported results without statistical analyses. Of 38 trials with results provided, 37 (97%) included safety endpoints or adverse events.

Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%; P=0.003). Of the 171 unpublished trials, 133 (78%) had no results available in ClinicalTrials.gov.

Researchers noted that nearly 300,000 study participants were exposed to the risks of being in a medical study, but without societal benefits that come from reporting trial results. They described publishing trial results as an ethical obligation.

“Even when study investigators and sponsors make their results available in ClinicalTrials.gov, this should not absolve them from their obligation to publish data in a peer reviewed format,” the authors wrote. Peer review can identify study bias, ensure statistical rigor, places study results into context, and facilitates access by the rest of the scientific community.

“While the ability of ClinicalTrials.gov to display results is an important step forward, this capability is not a substitute for the peer review process,” they concluded.

Wednesday, October 30, 2013

Changing medicines

A comment by a friend got me thinking. She mentioned that the constantly changing guidelines occasionally make her skeptical of medical advice.

It is true that guidelines change. By the same token, though, all knowledge changes. There are different ways to model the function of knowledge change. Are we asymptotically approaching truth? Does each generation of scientists invest in a new explanatory model, which is then discarded some time down the line in favor of another—a new paradigm, not necessarily closer to the truth? Or are scientists continually confronting new problems, with different narratives, so we’re not so much finding new answers as dealing with new questions?

All these possibilities apply to medicine. Guidelines for, say, the optimal control of blood pressure don’t change simply because we have a better idea of what the perfect blood pressure is. We have a different array of blood pressure treatments than we did just a few years ago; we have a different understanding of the relationship between systolic and diastolic blood pressure; we think a lot more about patient preferences than we did 10 or 20 years ago.

Where does this leave us? I hope not with widespread disillusionment that medicine, after all, does not inexorably march towards truth and health. Like any other empirical caravan, we trundle along for a while, get lost, find a new byway, and discover that we weren’t lost at all, and now we are in an even better place than we thought possible. Or we discover that the folks with us are not merely passengers along for the ride, but they know how to drive as well as we can.

When you hear about changing health care, you might be worried about a loss of stability. I would say that understanding the world requires constant change, in a world of flux.

Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews. He is also a poet, journalist and translator in Yiddish and English. This post originally appeared at his blog.

Methicillin-resistant Staphylococcus aureus (MRSA) rates in Veterans Affairs (VA) medical centers continued to decline 5 years after a national initiative began, a study found.

The study will appear in the November issue of the American Journal of Infection Control, and was announced in a press release Oct. 29.

The MRSA Prevention Initiative, started in 2007, resulted in significant decreases in both the transmission of MRSA (17% for ICUs and 21% for non-ICUs) and health care-associated infection (HAI) rates within the hospitals (62% for ICUs, 45% for non-ICUs). It had been previously reported that in the first two years of initiative, both MRSA transmissions and HAIs continued to decrease in non-ICU settings (declining an additional 13.7% and 44.8%, respectively), while holding steady in ICUs.

The initiative includes screening every patient for MRSA, use of gowns and gloves when caring for patients colonized or infected with MRSA, hand hygiene, a focus on individual responsibility for infection control, and the creation of a MRSA Prevention Coordinator at each medical center.

Researchers wrote, “Detailed analysis showed that there were statistically significant declines in MRSA transmissions and MRSA HAIs in non-ICUs but not in the ICUs. The absence of statistically significant trends in the ICUs may be because MRSA transmission and MRSA HAI rates were low.”

Tuesday, October 29, 2013

Practice guideline overload

I think I am like many practicing physicians in my “love-hate” relationship with clinical practice guidelines. On the one hand, it is often helpful to look up a set of evidence-based recommendations on a particular clinical issue, and I feel particularly fortunate that the American College of Cardiology and the American Heart Association have collaborated to produce high quality guidelines on a wide-range of subjects relevant to my practice. On the other hand, I am well aware of the shortcomings of practice guidelines, including the limitations of the underlying evidence base, the challenge of synthesizing the available evidence into guidelines, and the often limited applicability of recommendations to clinical practice.

Even these well-known problems with practice guidelines don’t capture the broader issue of “guideline overload.” There are now so many guidelines, that the “old” problem of “keeping up with the literature” has been matched by the contemporary problem of “keeping up with the guidelines” and some areas of clinical practice have many competing guidelines with inconsistent recommendations. Just for yucks, I searched for “hypertension” on the National Guidelines Clearinghouse site and got a list of 548 relevant guidelines, all of which had met the strict criteria for inclusion on the site. Thanks a lot.

A related aspect of guideline overload is the challenge of caring for patients with multiple conditions, each of which may be the subject of recognized guidelines. A recent paper in the Annals of Internal Medicine (Ann Intern Med. 2013;159(3):161-168. doi:10.7326/0003-4819-159-3-201308060-00005) presented an interesting response, at least with regard to guidelines for preventive care. Researchers from NYU School of Medicine built a mathematical model to help clinicians prioritize preventive interventions (e.g. quitting smoking vs. losing weight) for patients with multiple co-morbid conditions. They limited the “inputs” to the US Preventive Services Task Force recommendations, and were clear that their effort was intended only as a “proof of concept,” but it seemed to me that the approach has real merit.

They used two different imaginary patients, and were able to show that their profiles of the most effective preventive measures were different. They conclude: “models of personalized preventive care may help clinicians prioritize … recommendations at the patient level. Future work may help determine whether model-based personalization is feasible at the point of care and is associated with improved health outcomes.”

In other words, if this kind of information can be presented to clinicians as they care for patients (say, by imbedding it in an EMR), and if it can be shown to make a real positive difference in how patients do over time (the real test of utility of everything we do), then this is a real advance. I agree!

What do you think?

Ira S. Nash, MD, FACP, is the senior vice president and executive director of the North Shore-LIJ Medical Group, and a professor of Cardiology and Population Health at Hofstra North Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and Cardiovascular Diseases and was in the private practice of cardiology before joining the full-time faculty of Massachusetts General Hospital. He then held a number of senior positions at Mount Sinai Medical Center prior to joining North Shore-LIJ. He is married with two daughters and enjoys cars, reading biographies and histories, and following his favorite baseball team, the New York Yankees, when not practicing medicine. This post originally appearedat his blog, Auscultation.

QD: News Every Day--Interns skipping the niceties of patient communication

First-year interns rarely do the little courtesies that could establish a rapport with patients, such as introducing themselves, and it may be because their teachers rarely do it, a study found.

Researchers followed 29 internal medicine interns at The Johns Hopkins Hospital and the University of Maryland Medical Center for three weeks in January 2012 and recorded whether the doctors applied five ways of etiquette-based communication: introducing oneself, explaining one’s role in the patient’s care, touching the patient, asking open-ended questions such as “How are you feeling today?” and sitting down with the patient.

Interns touched their patients (such as a physical exam, handshake or a gentle touch) during 65% of visits and asked open-ended questions 75% of the time. But they introduced themselves only 40% of the time, explained their role only 37% of the time and sat down during only 9% of visits. Interns performed all five of the recommended behaviors during 4% of all patient encounters, and were only slightly more likely to introduce themselves to patients during their first encounter than a later one.

In a follow-up study 6 months later, researchers surveyed 9 of the 10 interns, asking how often they believe they used the 5 communication strategies. The interns estimated they introduced themselves to their patients and explained their role 80% of the time and that they sat down with patients 58% of the time.

“Basic things make a difference in patient outcomes and they’re not being done to the extent they should be,” says study leader Leonard S. Feldman, MD, FACP, who is also one of the associate program directors of the internal medicine residency. “These are things that matter to patients and are relatively easy to do.”

The researchers suggested that internal medicine trainees may not do the little things that ease patients’ time in the hospital because their teachers don’t either. Simple steps to improve interns’ manners could include providing chairs and photos of the care team in patient rooms and adding lessons on etiquette-based communication to the curriculum.

Dr. Feldman said in a press release that when he brings trainees into a patient room on rounds, he has everyone introduce themselves. Even if it’s unlikely the patient will remember everyone, it creates a better relationship, he says, adding that modeling appropriate behavior for interns is a good place to start.

“The hospital is a dizzying place,” Dr. Feldman said. “It’s a new crew all the time—in the emergency room, on the unit, the day team, the night team, the nurses, the respiratory therapist, the pharmacist. By introducing ourselves, we can go a long way toward making the entire hospital experience a little less daunting.”

Monday, October 28, 2013

We can be disease proof

When you board a plane, as I do very often, I presume you count on the skill of the pilot. You know, of course, that the pilot can’t control everything. Just like the ship captains of old controlled ship and sail, but not wind and wave, so do modern airline pilots control the cockpit, but not the atmospheric conditions. But controlling the cockpit is good enough for me and my fellow frequent fliers. We know we can’t get a “guarantee” of a safe flight, but we also know that with a skillful captain at the helm of a properly assembled plane, the odds are overwhelmingly in our favor.

Well folks, I am here to tell you exactly the same is true of health. The differences are only these: your body is the plane and you are the captain.

Assuming your body is put together about like a body ought to be, and you wouldn’t be here if it wasn’t, then you can be the captain of your fate. You can be the master of your medical destiny. You can even be the boss of your DNA. You can be, in essence, disease-proof.

We can reduce our lifetime risk of all major chronic disease by an incredible 80%. We can even alter our gene expression through the power of lifestyle. DNA is not destiny. To a much greater extent, choices under our control determine our fate. We have scientific evidence to show that if we change our own behavior, we change the behavior of our genes. We can nurture nature.

But just like a captain needs to learn how to fly that plane, you need to learn how to navigate your body to health. Both enterprises are skill dependent. It takes will to want to be an airline captain in the first place, but it takes skill to fly the plane. Similarly, you need willpower to get to health, because you do have to care. But once you care, you will need skill-power to get there from here. You and those you love really can be disease proof, but it takes skill. Fortunately, a lot less skill than flying a plane. Maybe it’s more like learning to ride a bike.

I have the skills needed to reduce my lifetime risk of any major chronic disease, heart disease, cancer, stroke, diabetes, dementia, by 80% and I want to pay it forward.

We have known this is possible for literal decades, but it’s a case study demonstrating that knowledge isn’t power. Knowing what isn’t the same as knowing how. Knowing how is all about skill-power. Disease-Proof is all about knowing both what and how.

The book lays out the case and presents the ironclad evidence for this 80 percent reduction in the risk of all chronic disease that is within reach of us all. It highlights what this would mean if we applied it to ourselves, and those we love. We might sum that up by noting simply this: healthy people have more fun! Better health means a better life. Longer, too, in all probability. The combination of more years of life, more life in years is about the best gift you can give yourself, and it’s the gift that keeps on giving, because if you know how to get there from here, you, too, can pay it forward to everyone you love.

What do I mean by “skill-power”? Well, for instance, let’s imagine you have a sweet tooth, as most of us do. Trying to file that down to size so it doesn’t become a sweet fang that takes over your life is usually very hard. It could be all about giving up your favorite desserts and just toughing it out. That’s the willpower approach.

When that approach fails, as it generally does, we beat up on ourselves (and sometimes one another) for not having enough willpower. But just as time and wind and rain can wear away even mountains, so can time and effort and frustration wear down even a mountain of willpower. Yes, will matters, and there are ways to maximize it (that, too, is addressed in Disease-Proof). But when even a mountain of willpower isn’t enough, then willpower is no longer the problem.

What if instead of giving up your favorite dessert, you give up gram after gram of sugar from your diet by trading up foods that didn’t need to be sweet in the first place? You won’t miss sugar from pasta sauce, after all. You won’t miss it in crackers, either. I refer to this as “stealth” sugar, sugar in foods we don’t consider sweet. There is a lot of it, but most people don’t know it’s there, let alone where it’s hiding. The good news is that when you find out, you can easily trade up to choices in the same categories that don’t have the added sugar (without spending more money, by the way).

And then, the news gets even better. Taste buds are very malleable little fellas, they learn to love the foods they’re with. That’s why you probably love way too much sugar and salt right now. Your taste buds have been “corrupted” by the unnecessary processing of the modern food supply. But that same food supply provides really good options in every category, and if you know which ones those are, they are all you need to rehabilitate your taste buds. You really can learn to prefer and love the very foods that love you back.

In the end, after taste bud rehab mediated by skill-power, you can give up that too-sweet dessert with no force of will, but just because you don’t like it anymore. Your newly rehabilitated taste buds will tell you it is too sweet, and you will trade up by choice, without effort and permanently. That’s what skill-power can do. The book is filled with an entire inventory of just such skills.

We know, as well, that we are all generally far too sedentary, and that just sitting more and moving less can take literal years off our lives. But fitting “exercise” into a crammed schedule can prove daunting to even an indomitable will. But there are in fact, ways to exercise without exercising, by having recreational fun. There are ways to space activity bursts directly into your work day, and get those elusive 30 minutes of physical activity without ever leaving the office (or living room). Such approaches require knowledge of, and access to, relevant tools and program and resources. Such solutions require skill. Skill can be acquired. Skill can be shared.

That is why my co-author, Stacey Colino, and I wrote Disease-Proof. The skill set for healthy living can be shared. So, quite simply, it should be. We’ve done our best to do exactly that.

These days, most books about health will tell you there’s just one thing to focus on: to lose weight, or find health, or stop aging. But those who read my columns routinely know I don’t accept any such nonsense. What worthwhile aspect of your life is all about just one thing? No one emotion makes a relationship. No one word makes a conversation. No one outfit makes a wardrobe. No one food makes a diet. No one tool can do every job (I am a pretty good carpenter, and have a well-stocked wood shop). No one skill makes a business. Life’s activities inevitably require a skill set. Imagine a pilot being great at takeoff, but lousy at landing. Or really good at controlling altitude, but not so good at turning. No thanks, I want a pilot with the full skill set for flying a plane, if you please.

Similarly, you should want, and you can have, the full skill set for healthy living. That was the idea that turned into Disease-Proof. We have known for decades how to slash the risk of all serious chronic diseases, but only some of us have the skills to turn that knowledge into the power of better living. That shouldn’t be. Everyone should have that power.

I do think the best way for that to happen is for our culture and our environment to change. I think health should be on a path of much lesser resistance, and then it wouldn’t be on the road so seldom taken. My day job is devoted to accelerating just such changes, and we address them in Disease-Proof. But I don’t recommend you hold your breath while waiting on the world to change. The world changes slowly and you and those you love can’t afford to wait. Fortunately, there’s no need. The right skill set can give you mastery over health (and weight) in the world as it is.

It’s not rocket science. It’s not even plane travel. The relevant skills aren’t trivial, but they aren’t really hard, either. You can have them, but you have to get them. Remember you once had to learn how to ride a bike. But then … you’ve known how ever since.

Without the right skill set, health is elusive. You can’t get there from here. The relevant skills are yours for the taking, and with them, you and those you love truly can be to an astonishing degree, disease-proof. I want that to happen, and will be deeply gratified to be any part of the reason it does.

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.

Bariatric surgery appears to be more effective for weight loss and type 2 diabetes remission than nonsurgical interventions like diet and exercise, but the long-term effects remain uncertain, according to a new meta-analysis.
Researchers performed what they believed to be the first systematic review and meta-analysis of randomized, controlled trials that directly compared bariatric surgery with nonsurgical treatment. Included trials involved patients with a BMI of at least 30 kg/m2; reported data on body weight, cardiovascular risk factors, quality of life or adverse events; and had at least 6 months of follow-up. Eleven studies involving 796 patients with a mean BMI at baseline of 30 to 52 kg/m2 were included. The results were published online by BMJ Oct. 22.
Overall, patients who received bariatric surgery lost more weight, were more likely to have remission of type 2 diabetes, had greater improvements in quality of life, used less medicine, and had a greater decrease in waist circumference and triglyceride levels and a greater increase in high-density lipoprotein cholesterol levels than those who received nonsurgical interventions. Blood pressure changes and levels of total and low-density lipoprotein cholesterol levels did not differ according to whether patients received surgery or nonsurgical treatment. No patients were reported to have died or to have had cardiovascular events during follow-up. Fifteen percent of patients who had malabsorptive bariatric surgery developed iron-deficiency anemia, and 8% of patients had repeated surgery.
The authors concluded that compared with nonsurgical measures, bariatric surgery leads to more weight loss and higher remission rates of type 2 diabetes and the metabolic syndrome in obese patients. However, they also noted that their meta-analysis involved only 11 small trials with a maximum of 2 years’ follow-up. “The evidence beyond two years of follow-up, in particular on adverse events, cardiovascular diseases, and mortality remains unclear and calls for further research on the topic,” they wrote.

Friday, October 25, 2013

Focus on Obamacare ignores the other health care revolution

While everyone has been busy losing their minds about Obamacare, people are missing the less visible revolution in American health care. This quiet revolution started years ago, and the basics are very simple: Shift costs away from insurers and place them in the hands of doctors and patients.

For patients (at least, the ones with insurance) this has meant a dramatic shift toward cost sharing as employers purchase less-unaffordable health plans. These plans, with their Byzantine system of moving more costs to providers and patients, are understood by no one except their creators.

Ask people who should know to explain the difference between “out-of-pocket,” “deductible,” “co-pays,” and “co-insurance” and you’re likely to learn nothing at all.

It doesn’t take a conspiracy theorist to find that the confusion generated is intentional. Most people look at how much money the benefits will pull from their paycheck and move on to trying to make ends meet.

The kind way to describe this is increasing patients’ “moral hazard” by giving them a personal stake in their health care costs. What I actually see in my office is people putting off necessary care for fear of large bills. (This seems to happen whether or not the service is actually “covered”. Most people I see don’t understand their insurance well enough and simply act in a way to avoid potential bills.)

But insurers aren’t just shifting costs to patients. An increasingly complex system of “incentives” is taking over doctors’ payments, making our current “fee-for-service” system even less comprehensible. The idea is a good one: Shift from paying doctors for how much they do, which may drive up costs since doctors get paid for “more,” to paying doctors for meeting certain goals. These goals are supposed to encourage doctors to focus more on quality than on volume.

In the trenches of everyday practice, it’s not working (or, if you’re more suspicious, it’s working perfectly by cutting doctors’ pay). I received a spreadsheet last week explaining my “incentive” payments from various insurers for the last quarter. From what I could tell, I made more money because I prescribe few brand-name drugs, but lost money because the number of my patients who went to the hospital was arbitrarily “too high.”

I can control whether or not I give proper advice to diabetics (something hard to measure), and whether I prescribe proper drugs to them (something marginally easier to measure). I can’t, however, control how often they go to the hospital. No one has shown that penalizing doctors for admissions or ER visits improves the care of their patients. No one has shown that these admissions measure how “good” a doctor is.

At the same time, each insurer has their own program of incentives, leaving doctors to steal time from their patients and their families to try to puzzle through the often contradictory requirements.

No one knows what Obamacare is really going to do to American health care. It may be a disaster, a boon, or more likely a bit of both. But fighting about it distracts from the on-the-ground reality: Primary care doctors, already in short supply, are being squeezed from every direction. As more Americans become insured, fewer doctors will subject themselves to the inane chaos of reimbursement. The only important question left is “Cui bono?”

Peter A. Lipson, ACP Member, is a practicing internist and teaching physician in Southeast Michigan. After graduating from Rush Medical College in Chicago, he completed his internal medicine residency at Northwestern Memorial Hospital. This post first appeared at his blog at Forbes. His blog, which has been around in various forms since 2007, offers "musings on the intersection of science, medicine, and culture." His writing focuses on the difference between science-based medicine and "everything else," but also speaks to the day-to-day practice of medicine, fatherhood, and whatever else migrates from his head to his keyboard.

The American Association of Clinical Endocrinologists, the American College of Endocrinology and the Obesity Society recently released joint guidelines on healthy eating to prevent and treat metabolic and endocrine disorders.
The comprehensive guidelines are meant to address gaps in clinicians' and patients' nutritional education, the authors wrote, and purposely avoid using the term "diet," opting instead for the terms "meal plan" and "eating or dietary pattern." Areas addressed include a definition of healthy eating and nutritional recommendations for weight management, cardiovascular health, diabetes mellitus, chronic kidney disease, and bone health, along with specific recommendations for pregnant and lactating women and elderly patients.
The full guideline was published by Endocrine Practice and is available free of charge online.

Thursday, October 24, 2013

Leaders in academic medicine should channel Ganesh

Last night I had a wonderful dinner with a previous family medicine resident and his family. He now works as a hospitalist. I knew that he was celebrating Ganesh’s birthday -Ganesh Chaturthi 2013: Hindus Celebrate Birthday Of Lord Ganesh For Auspicious Beginnings Being fascinated with religions, I asked about Ganesh and he and his wife taught me. I knew that Ganesh favored learning, but I was unaware of the phrase “remover of obstacles.” Hindus pray to Ganesh when starting new projects, as he removes obstacles to success.

Although he is known by many attributes, Ganesha’s elephant head makes him easy to identify. Ganesha is widely revered as the remover of obstacles, the patron of arts and sciences and the deva of intellect and wisdom. As the god of beginnings, he is honoured at the start of rituals and ceremonies. Ganesha is also invoked as patron of letters and learning during writing sessions. Several texts relate mythological anecdotes associated with his birth and exploits and explain his distinct iconography.

What struck me during our conversation was the concept of removing obstacles! Can you remember praising a leader for removing obstacles? What I see in medicine today and in medical education today is a series of obstacles! Who is working to remove those obstacles?

While Medicare is in many ways a huge success as a health care program, unfortunately it often represents the anti-Ganesh. CMS creates rules that really are just obstacles to care. CMS focuses on payments and the budget. The rules, however well-intentioned, create obstacles. How can we decrease the obstacles to spending adequate time with patients, writing intelligent notes and decreasing health care costs.

The American Board of Medical Specialties and Accreditation Council for Graduate Medical Education continue to add rules for residencies. Residency programs spend inordinate time in documentation, while residents spend less time with patients and seemingly are not learning medicine as well (decreased board pass rates).

We in academic medicine, we in medical societies, and perhaps other health care leaders should reframe our conceptualization of health care. We need to channel Ganesh and work to remove obstacles. We need leaders who refuse to accept obstacles!

db is the nickname for Robert M. Centor, MD, FACP. db stands both for Dr. Bob and da boss. He is an academic general internist at the University of Alabama School of Medicine, and is the Associate Dean for the Huntsville Regional Medical Campus of UASOM. He also serves as a frequent ward attending at the Birmingham VA Hospital. This post originally appeared at his blog, db's Medical Rants.

QD: News Every Day--Brief screening for cognitive impairment may not affect outcomes

Brief screening instruments can detect cognitive impairment, but the results may not have an effect on clinical care, according to a new study.

Researchers performed a systematic review for the U.S. Preventive Services Task Force to examine whether brief cognitive screening instruments were diagnostically accurate and to investigate the benefits and harms of interventions for early cognitive impairment. Five key questions were addressed:

1. Does screening for cognitive impairment in community-dwelling older adults in primary care-relevant settings improve decision-making, patient, family or caregiver, or societal outcomes?
2. What is the test performance of screening instruments to detect cognitive impairment in elderly, community-dwelling primary care patients?
3. What are the harms of screening for cognitive impairment?
4. Do interventions for MCI or mild to moderate dementia in older adults improve decision-making, patient, family or caregiver, or societal outcomes?
5. What are the harms of interventions for cognitive impairment?

The study was funded by the Agency for Healthcare Research and Quality and was published online by Annals of Internal Medicine on Oct. 22.

The study authors found that the Mini-Mental State Examination is the most thoroughly studied instrument for detecting dementia but pointed out that it can't be used without cost. Publicly available instruments that performed adequately included the Clock Drawing Test, Mini-Cog, Memory Impairment Screen, Abbreviated Mental Test, Short Portable Mental Status Questionnaire, Free and Cued Selective Reminding Test, 7-Minute Screen, and Informant Questionnaire on Cognitive Decline in the Elderly. The review also found that FDA-approved medications for Alzheimer's disease and caregiver interventions yielded only small benefit of uncertain clinical importance. Evidence was also limited for cognitive stimulation and exercise in patients with mild to moderate dementia or mild cognitive impairment.

The authors noted that their review had a narrow scope and didn't address comparative performance of screening instruments or the possibility of combining screening instruments, among other factors. However, they concluded that although brief screening instruments can detect cognitive impairment, it is not confirmed whether screening and early diagnosis improve decision making or outcomes.

"Despite a large body of evidence spanning decades of research, it is still unclear whether FDA-approved medications, caregiver interventions, cognitive interventions, or exercise interventions in persons with earlier detected cognitive impairment have a clinically significant effect," the authors wrote. "How best to identify persons with cognitive impairment and understanding how and whether early identification affects important decision making is much needed to address this common, growing, and costly health condition."

Wednesday, October 23, 2013

Are PSSA infections coming back?

On the way to Lac St. Francois a couple weeks ago, we drove near St. Albans, Vt., the location of the hospital outbreak mystery described in a recent posts by Mike Edmond, MD, FACP, (You may remember, the “case of the circumstantial evidence of a complicated conspiracy of hospital personnel using laboratory control strains to intentionally infect patients in order to ruin a doctor who claimed to have uncovered an illegal kickback scheme involving radiology services ….” Yeah, that’s the one!).

In expert testimony from this case, the statement is made that penicillin-susceptible Staphylococcus aureus (PSSA) are extremely rare (“less than 2% of all S. aureus isolates”). This widely-held assumption (that PSSA are basically “extinct”) is incorrect, and in some centers there appears to have been a substantial increase in PSSA over the past few years. See this report from John Crane that 15% of all S. aureus from ICU patients in Buffalo, N.Y., are now PSSA, and this report from IDWeek 2012 that PSSA accounted for 20% of all MSSA (and 13% of all S. aureus) from positive blood cultures in the Kaiser Permanente system (regional reference laboratory in Los Angeles). We plan to examine this issue as well in the next round of our nationwide S. aureus resistance surveillance.

The perception that PSSA no longer exist persists in part because many labs don’t test or report the drug (to detect inducible beta-lactamases, labs have to perform a beta-lactamase test on any S. aureus that tests susceptible, before reporting it).

Why is this important? It is another indication of how complex is the epidemiology of S. aureus, demonstrating that emergence and virulence are not necessarily tied to resistance, and that the “loss” of a drug may not be the end of the story, and also, of course, as a reminder that the drug of choice for PSSA is penicillin.

Daniel J. Diekema, MD, FACP, practices infectious diseases, clinical microbiology, and hospital epidemiology in Iowa City, Iowa, splitting time between seeing patients with infectious diseases, diagnosing infections in the microbiology laboratory, and trying to prevent infections in the hospital. This post originally appeared at the blog Controversies in Hospital Infection Prevention.

QD: News Every Day--Lack of knowledge about risks of cancer overdiagnosis widespread among doctors, patients

Physicians who don’t know enough about risks of overdiagnosis for cancer screenings has led to too many patients being uninformed as well, a study concluded.

Researchers conducted an online survey of 317 U.S. men and women ages 50 to 69 years to find out how many patients had been informed of the risks of overdiagnosis and overtreatment, as well as and how much overdiagnosis they would tolerate when deciding whether to start or continue screening.

Of the entire sample, only 30 (9.5%) people recalled that their physician had informed them about the possibility of overdiagnosis and overtreatment. Nine of these patients indicated that their physician quantified the risk of overdiagnosis, but in 8 of those cases, patients recalled overestimates or underestimates of the risks for these screenings than the figures reported in the medical literature.

Just over half (51%) of all participants would not undergo a screening that hypothetically resulted in more than 1 overtreated person per 1 life saved from death due to cancer, while nearly 59% would continue cancer screening that they are already receiving regularly, even if they learned that the test results in 10 overtreated persons per 1 life saved from cancer death. And, 69% of the sample indicated that they would not start screening if overdiagnosis was 10 or more cases per 1 life saved, such as in mammography and PSA testing.

Researchers noted that the large number of uninformed patients might be due to the large number of physicians who know little about screening harms, pointing out that a national sample of 412 U.S. primary care physicians showed that nearly 34% of doctors could not provide a correct estimate of overdiagnosis for mammography and nearly 43% could not do so for PSA testing.

“Our results should prompt medical educators to improve the quality of teaching about screening and encourage medical journal editors to enforce clear reporting about overtreatment when publishing results on the effectiveness of cancer screening,” the authors wrote. “These means may not be sufficient but would be a first step toward enhancing the number of physicians and patients who thoroughly understand the potential consequences of taking a cancer screening test.”

An accompanying editorial used fairly frank language to drive home the point that more research is needed.

“Our patients have been taught to think differently about screening. There are no harms. It’s always good to know. It is just about gathering information. Of course you want it. It is a brain-dead decision,” the editorial states. “In reality, the truth is more nuanced. There are benefit and harms to consider in screening—just as there are in treatment. There’s no longer any argument about this. Even the American Cancer Society signs on to the idea of overdiagnosis—using the word in its materials on breast, lung, and prostate cancer screening. The arguments are, instead, about the magnitude of the benefits and harms.”

Tuesday, October 22, 2013

Medical errors earn hospitals money. Who knew?

Though I have been accused by various commenters as protecting my own specialty when I point out excesses, flaws and conflicts of interest in the medical profession, this accusation would be handily dismantled after a fair reading of prior posts. Indeed, my own specialty of gastroenterology and my own medical practice has felt the effects of the honed Whistleblower scalpel. If an individual or an institution will not willingly engage in self-criticism, then it creates a credibility gap that may be impossible to bridge. If you want a seat at the table, then arrive exposed and humble.

A study was published in the prestigious medical journal JAMA, the Journal of the American Medical Association in April 2013 publishing what we have known for decades: Hospitals make more money when medical errors are committed. As an aside, I have much more respect for JAMA than I do for the AMA, but I’ll resist the strong temptation to digress.

Here’s how it has worked in the past. If a patient is hospitalized with an inflamed gallbladder and is discharged a day later after surgery, the hospital would be reimbursed according to a specific fee schedule. (Payment systems for hospitalized patients are more complex than this, but accept the above example for the moment.) If this same patient undergoes complications after surgical removal of the gallbladder, the hospital would be paid more. If an infection at the incision site, or the patient develops a reaction to medication that may lead to more testing, then the hospital bill will understandably increase. The issue is if hospitals or physicians should be able to charge more for extra care that was preventable.

There is an inexorable movement away from fee-for-service medicine which antagonists argue lead directly to excessive care. Value based care is the new concept where quality, not quantity, will be measured and reimbursed. There is a growing Never Events list where certain medical complications that are designated as events that should never happen, will never be reimbursed. While this concept sounds attractive in a sound bite, my view on Never Events is more nuanced.

The argument to withhold payment for care that resulted from medical error is potent. Keep in mind that defining a medical error is not as easy as it sounds. One can easily imagine how easy it would be to confuse a medical complication, which is a blameless event, from an error or a negligent act. If I perform a colonoscopy and a perforation develops as a complication, should the hospital and surgeon I consult not be paid for the additional care that would be required?

Would every profession consent to returning fees for mistaken advice or service? Do you agree with the following?• Financial advisors should return fees if investment performance is below a designated threshold or differs from their peers.• Attorneys who have been found on appeal to have offered ineffective legal arguments at trial, should surrender their fees.• A professional baseball player who drops a fly ball should lose a day’s pay.• A newspaper publisher should offer a rebate to all readers if a news story is found to be inaccurate owing to a lack of proper editorial oversight.

I realize that medical mistakes cost money, as do some of the hypothetical examples above. I also accept that financial incentives can change behavior and can be an effective tool. But every human endeavor has a finite error rate and we should be cautious before using a financial drone attack against only the medical profession. Let’s use a scalpel here and not a sledge hammer. And those of you outside of medicine, explain why your occupation should be spared from this reform strategy?

If to err is human, and doctors are human, then should we punished for our humanity?

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

Free prostate screening! What's the catch?

I just got an e-mail from a hospital where I sometimes practice with a picture of two aging but clearly active and vital men standing on a beach with the words “Free Prostate Cancer Screening” printed below in an attractive font. The hospital is sponsoring the screening, along with the urology clinic affiliated with the hospital. The advertisement gives guidelines for who should avail themselves of this service, including men as young as 35 years old if there is a family history of prostate cancer and otherwise 55 and older, with no maximum age.

Prostate cancer screening, that is checking a man’s prostate cancer via a rectal exam and also performing a blood test for prostate specific antigen (PSA) has been of questionable utility for decades, and finally last year the U.S. Preventive Services Task Force came out with their strongest statement ever, saying they recommended against prostate cancer screening. In prior recommendations they had questioned the utility of screening men at any age and had recommended that men over the age of 75 not be screened. Evidence piled up, however, showing that prostate cancer was significantly overdiagnosed, with many men being diagnosed and treated for prostate cancers which would never have caused them any harm if left undetected, and that the screening process itself, with biopsies and anxiety inducing repeated tests resulted in more harm than any help that would come of early detection. The members of the Task Force, 16 nationally recognized MD and PhD volunteers who specialize in preventive medicine and public health, decided on this basis to recommend categorically against prostate cancer screening.

How is it possible that early diagnosis of cancer is bad? Cancer cells come and go in our bodies all the time. Some of them stay and produce tiny tumors that never cause us harm, others are eliminated by the immune system and by the normal processes of cell aging and death. Only some cancers become evil and endanger or kill us. If we detect the ones that would have caused us no harm, we then get treatment which is painful and harmful, expensive and dangerous. People die of over zealously treated cancers. Some particularly aggressive cancers, if detected early, will still kill us, but we will spend more of our lives having surgeries and chemotherapy than we would have if we had waited until they caused symptoms.

Some cancers, of course, can be caught and eradicated at just the right time and finding these cancers can save our lives. Certain cancers are more likely to be cured when caught early than other ones. Colon cancer is frequently curable if caught early and fatal if allowed to spread. Some breast cancers are that way. Prostate cancer is extremely common as men age, and early autopsy studies concluded that if a man lived to be 100, he would have a nearly 100% chance of having prostate cancer if one were to check his prostate after he died of something else. People do die of prostate cancer, but detecting it early does not seem to make much difference in outcomes, at least not enough difference to outweigh the harms of screening.

This information is not a secret. For a time, the recommendation not to screen for prostate cancer was quite controversial. The American Urological Association, the professional organization of the doctors who biopsy prostates and operate on prostate cancers, did continue to recommend regular rectal exams and PSA testing until the last year or so, when they joined the American Cancer Society in recommending against screening before the age of 40 and after the age of 70, or for men with a life expectancy of less than 10-15 years. For the rest, they recommended screening only after discussing the risks and benefits of doing so with a doctor, with a shared decision making approach involving both science and the patient’s preferences.

I thought perhaps this e-mail I got was an artifact of an earlier age, and that this hospital had somehow failed to hear the news that screening all comers age 35 and above is a bad idea. Then I opened my local paper and found that one of our local hospitals was sponsoring a free prostate screening day with our local urologist. I Googled Free Prosate Screening and came up with over 12 million results, some of which were recommendations against screening, but most were advertisements for free screenings, rectal exams and PSA testing.

Perhaps the urologists are not just doing a rectal exam and a blood test, but are dutifully discussing the risks and benefits of screening and engaging in shared decision making. But I doubt it. This subject takes a long time to discuss and shared decision making requires that the doctor explore the patient’s expectations and values. Free screening clinics usually have lots of people and essentially no time for discussion. Perhaps symptom-free 80-year-olds would be turned away, but I can’t really picture that. Instead I picture a waiting room full of apprehensive guys, many without access to a doctor willing to discuss preventive care with them, being hurried through a brief encounter with a doctor, a quick blood draw and then being handed a few possibly informative booklets which they will most likely never read.

Evaluating for prostate cancer is not a terrible idea if a patient has symptoms that might go along with prostate cancer, things like fatigue and bone pain and sometimes difficulty urinating or blood in the urine. This is not considered screening. This is a well thought out exam to help diagnose a disturbing symptom.

But what if a man just wants to know if he has prostate cancer, and then discuss the options of treating it or watching it with his doctor? Wouldn’t PSA and rectal exam tests be useful for that? Such a can of worms. It is difficult for many men to be comfortable knowing that they have a cancer and not do anything about it. I have had patients who were at peace with this approach, but they were few. In America it is dramatic and somewhat embarrassing to admit to having cancer, but keeping it a secret is difficult too, especially from well-meaning family. Also, having a normal PSA and rectal exam does not mean that a man is free of prostate cancer. Using a cutoff of a PSA of 4, about 15% of men screened with these tests had prostate cancer when biopsies were performed, in a study published in 2004. It is likely more cases would have been found had they used more modern biopsy techniques which sample 8-12 sites rather than the 6 samples taken by old protocols. “Normal” levels of PSA were adjusted down after this, labeling more healthy patients as abnormal.

So, bottom line, free prostate cancer screening is not free. PSA testing and rectal exams are not good ways to detect prostate cancers that would cause harm and could be cured by early treatment. Follow-up PSA testing may or may not help to detect more aggressive cancers but may not be paid for by insurance since PSA testing is deemed not to be very accurate. Prostate cancer is a bad disease, in many cases, and we need to continue to look for ways to detect the cancers that can be cured and effectively treat the ones that cause symptoms. But this does not involve foisting outdated screening routines on an unsuspecting public.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.

Researchers at the University of Montreal studied billing information of over 870 Quebec practitioners (half of whom were women) who were treating elderly diabetic patients. The Canadian Diabetes Association guidelines state all patients aged 65 and over with diabetes must undergo an eye exam by an ophthalmologist or optometrist every 2 years. They must also receive three prescriptions for specific drugs, including statins, and are recommended to undergo a complete medical examination annually.

Results appeared in the Revue d’Épidémiologie et de Santé Publique (Journal of Epidemiology and Public Health).

Women had significantly rates of compliance with practice guidelines. They were more likely than men to prescribe recommended medications and to plan required examinations, researchers noted. Among middle-aged doctors, 3 out of 4 women required their patients to undergo an eye examination, compared to 70% of their male counterparts. Also, 71% of women prescribed recommended medications compared to 67% of male doctors. A similar proportion of women prescribed statins, 68% compared to 64%. Finally, 39% of female doctors specifically asked their patients to undergo a complete examination compared to 33% of male doctors.

But in terms of productivity, male doctors reported an average of nearly 1,000 more procedures per year compared to women. Age of the doctor was also a factor. The younger the doctors, the less significant the differences.

Researchers noted in a press release that while a more productive doctor would seem more profitable for a hospital, doctors who take the time to explain problems to their patients may avoid these patients returning after a month because they are worried about missing details.

Monday, October 21, 2013

Being less dense about breast cancer screening

I was privileged recently to attend a fund-raising event for Are You Dense, Inc., a non-profit organization dedicated to helping women with dense breast tissue get the best early detection services modern medicine can offer. Dense breast tissue both makes cancer more likely, and harder to see on standard mammograms.

I have addressed the topics of medical screening and mammography before. The former works best only when the right people get the right test. Otherwise, screening, which is quite literally looking for trouble, is apt to find just that. A false sense of security from a “normal” mammogram in a woman with dense breast tissue is just the kind of trouble we want to avoid. And while mammograms save lives, they have limitations, and the best screening programs account for them.

I have also done some homework on the topic of dense breast tissue and learned a bit about how prevalent and important this condition is. But it’s always best to get information directly from an expert source. My conversation with the Are You Dense founder, Nancy Cappello, PhD, was as informative as her efforts are inspiring. With her permission, I share her answers to some of the questions I posed.

1) What is ‘dense breast tissue,’ and why does it matter?

There are four categories of breast tissue composition. This scale is known as the BIRADS density scale and has been used by radiologists to standardize density reporting since 1993. The categories are divided in quartiles and range from fatty to scattered to heterogeneously to extremely dense. As a woman’s density increases, the sensitivity of the mammogram decreases. While the category of a woman’s dense tissue composition is usually shared by the radiologist in a report to her referring doctor, this information is seldom shared with the patient. Dense breast tissue is comprised of less fat and more connective and glandular tissue which appear white on mammographic X-ray. Cancerous tumors also appear white making it nearly impossible to ‘see’ the tumor. Cancer, hidden by dense tissue, can go undetected for years and once discovered is at a later stage, conveying less treatment options and worse survival outcomes.

2) What is the right approach to early breast cancer detection with dense breast tissue?

A woman needs to know her breast tissue composition and discuss its impact, along with additional risk factors, with her health care providers as she plans her personal screening surveillance. The scientific literature for two decades has concluded that dense tissue is the strongest predictor of the failure of a mammography screening to detect cancer. It is also a well-established predictor of breast cancer risk. The common convention is that women who have greater than 50% density are considered to have dense breast tissue, namely heterogeneously and extremely dense. About 40% of women of mammographic screening age are dense. Woman must understand that if she has dense tissue her normal mammography report results may be anything but normal, as cancer may be hidden by the dense tissue as in my case. My advanced stage IIIC cancer was discovered within weeks of a normal mammogram. Even though it is known by the medical community of the impact of dense tissue on the accuracy of the mammogram, most doctors do not share this information with women. This fatal flaw in breast cancer screening compelled me to start Are You Dense, Inc., to standardize density reporting across the country and the globe.

3) What is the evidence that modified approaches to early detection make a difference with dense breast tissue?

There are dozens of studies that conclude that screening technologies, such as MRI and ultrasound, added to mammography significantly increase the detection of small, early, invasive cancers. MRI and ultrasound technologies are more sensitive to finding cancers in women with dense breast tissue that are invisible on mammogram, known as mammographically occult cancers. As with every technology, there are benefits and risks. One of the risks of MRI and ultrasound is that there will be more false positives when the suspicious finding goes directly to biopsy without a diagnostic workup. Two national surveys and one state survey have reported that women want to know their dense tissue composition. Women would rather have a false positive than a missed positive—a normal mammogram, yet hidden invasive cancer undetected until palpable thus at a later stage. Women with dense breasts need to be informed of the risks and benefits of mammography screening including its impact on delayed diagnoses and advance cancer.

4) What are the obstacles to universal application of optimal methods of early detection?

Opponents to legislative efforts lament that density reporting will cause unnecessary trauma, confuse and frighten women, although we have not been presented with any surveys or studies confirming these assertions. Opponents also report a shortage of radiologists, insufficient screening codes and work-flow issues. All these issues of the profession will not be solved by withholding a woman’s dense tissue composition from her. We cannot accept the current standard that a patient should only have the information her doctors choose to tell her, thus denying her the ethical and moral doctrine of informed consent. Since the enactment of CT’s density reporting law, published data show a statistically significant increase in the detection of early, invasive, node-negative breast cancer by adding ultrasound screening to women with dense breast tissue and otherwise normal mammograms. While analog mammogram is the only screening tool that has shown, through randomized control trials, a reduction in deaths, we have not been presented with any research that invasive cancers not visible on mammogram and detected by other screening tests are any different and therefore less clinically significant.

5) What is most needed now by Are You Dense, Inc., to advance its mission?

Since our Connecticut density reporting legislation in 2009, hundreds of women have contacted me with the same tragic and compelling story, delayed diagnoses and advanced cancer with months of a normal mammogram. Some of our patients-turned-advocates have died as they pursued state density-reporting legislation. Reporting the scientific research, we have enlisted champion legislators and physicians in our campaign to ensure that all women are aware of their breast tissue composition and have access to reliable screening tools. As a result of the flurry of interest in legislation, I started Are You Dense Advocacy, Inc., in 2011 and as of this writing, 12 state density-reporting laws have been enacted.

We need supportive medical professionals, health industry personnel, patients-turned-advocates and the public to join our campaign for universal density reporting. The American Society of Breast Disease and the Association for Medical Imaging Management support our density-reporting efforts. We also need financial support to advance our impactful education, outreach and advocacy campaigns. Connecticut Congresswoman Rosa DeLauro is poised to reintroduce a federal density reporting bill and we are working with the FDA for revisions to the MQSA regulations to include density reporting in the patient’s mammography results

6) What would it take to be able to say mission accomplished?

Mission is accomplished when uniform density reporting exists across the globe and women have access to reliable screening tools to detect cancer at its earliest stage. We look forward to data confirming that legislative efforts improve breast density knowledge and assist women in discussions with their health care providers about their personal breast-screening protocol. We also expect dense breast tissue to be included in breast cancer risk assessment models. Because of our impactful mission, we anticipate a reduction in the incidence of regional and distant disease and deaths from breast cancer. Isn’t that what we all desire for ourselves and our loved ones?

I was left with a rhetorical question I did not ask Nancy. If there is a better protocol and it’s the law in 12 states, why isn’t it the law in all 50? We don’t need legislation to tell doctors what to do, but legislation ensures not only a consistent elevation of clinical practice standards, but also the appropriate coverage/reimbursement so that everyone gets the medical care we all know our loved ones deserve.

We don’t know how to make breast tissue less dense, but Are You Dense is showing us how to be a bit less dense about the need to tailor breast cancer screening to suit specific circumstances. Nancy’s laudable mission has come a long and impressive way already, but there are still lives at stake, and still miles—and 38 states—to go.

David L. Katz, MD, FACP, MPH, FACPM, is an internationally renowned authority on nutrition, weight management, and the prevention of chronic disease, and an internationally recognized leader in integrative medicine and patient-centered care. He is a board certified specialist in both Internal Medicine, and Preventive Medicine/Public Health, and Associate Professor (adjunct) in Public Health Practice at the Yale University School of Medicine. He is the Director and founder (1998) of Yale University's Prevention Research Center; Director and founder of the Integrative Medicine Center at Griffin Hospital (2000) in Derby, Conn.; founder and president of the non-profit Turn the Tide Foundation; and formerly the Director of Medical Studies in Public Health at the Yale School of Medicine for eight years. This post originally appeared on his blog at The Huffington Post.

QD: News Every Day--Obesity rates unchanged in recent years

The prevalence of obesity among adults did not change between 2009-2010 and 2011-2012, the CDC reported.

More than 78 million adults, or nearly 35% of the population, were obese in 2011-2012, with no significant change among either men or women from the years 2009-2010, the agency reported based on data from the National Health and Nutrition Examination Surveys.

In 2011-2012, 33.5% of men were obese, compared with 35.5% in 2009-2010. Among women, the obesity rate was 36.1% in 2011-2012 and 35.8% in 2009-2010.

Other reported obesity rates included:• In 2011-2012, the prevalence of obesity was higher among middle-aged adults (39.5%) than among younger (30.3%) or older (35.4%) adults.• Among non-Hispanic black adults, 56.6% of women were obese compared with 37.1% of men.• In 2011-2012, the prevalence of obesity was higher among non-Hispanic black (47.8%), Hispanic (42.5%), and non-Hispanic white (32.6%) adults than among non-Hispanic Asian adults (10.8%).

Friday, October 18, 2013

QD: News Every Day--Which placebo for migraine works best?

Sham acupuncture and sham surgery for migraine were associated with better response rates than oral placebos, a meta-analysis found.

To determine whether different types of placebo treatments are associated with different effect sizes, researchers conducted a meta-analysis of 79 randomized clinical trials on the prophylaxis of migraine with an observation period of at least 8 weeks after randomization that compared an experimental treatment with a placebo control group.

Responders were defined as patients who had a reduction in migraine frequency of at least 50%, or if those data were not available, patients with at least a 50% reduction in the number of migraine days, with at least a 50% reduction in the number of headache days, with at least a 50% reduction in headache scores, or with significant improvement as assessed by the patients or physicians.

The overall pooled proportion of responders in the active treatment groups was 0.42 (95% CI, 0.38 to 0.45) and in the placebo groups was 0.26 (95% CI, 0.22 to 0.30). Active treatment was significantly more effective than placebo treatment (RR, 1.40; 95% CI, 1.23 to 1.59). The proportion of responders with a more pronounced reduction of migraine frequency was greater for sham acupuncture (0.38; 95% CI, 0.30 to 0.47) and sham surgery (0.58, 95% CI, 0.37 to 0.77) than for oral placebos (0.22; 95% CI, 0.17 to 0.28).

“The context and meaning of a placebo treatment are more important than the placebo vehicle itself,” researchers noted. “However, the context and meaning of surgery, for example, differ considerably from those of an oral drug. Patients may develop greater expectations about treatments such as acupuncture and surgery because of the more elaborate and impressive treatment rituals. The higher level of attention and physical contact may also play a role. The most probable explanation for the apparently greater effectiveness of sham acupuncture and possibly sham surgery compared with placebo pills is thus their systematic association with contextual factors that are known to enhance placebo effects.”

Researchers noted that clinicians who treat migraineurs should be aware of placebos’ nonspecific effects and that these effects might differ between treatments.

The study may challenge the classic interpretation of randomized clinical trials that the treatment with the greatest specific effect compared with its placebo control is also the most effective one, the authors continued. An efficacy paradox occurs in which complex interventions with a small specific effect but a large placebo effect could be considered of little value while still being more effective than a simple intervention with a moderate specific effect but a small placebo effect.

An accompanying editor’s note stated, “As might be expected, the sham acupuncture and sham surgery control groups had a greater reduction of migraine frequency than the oral pharmacological placebo groups. Thus, in evaluating therapy for migraine prophylaxis, we learn from this review that like treatments should be compared, such as surgery treatment with sham surgery treatment and pill with sham pill. This important lesson extends far beyond migraine prophylaxis treatment.”

The bottom line, as the title of this post says, is that the proposed ACGME approach really applies an increasingly outdated 20th Century model of medical training to the vibrant 21st century subspecialty of clinical informatics. There is no question that clinical informatics training, like any other training, requires knowledge, skills, and experience. But the standard time-based, in situ approach to training likely will not build the capacity needed or provide a pathway that many who seek to join this profession can take.

One irony of this sort of approach is that OHSU was just awarded one of 11 grants from the American Medical Association (AMA) in their Accelerating Change in Medical Education initiative. Three schools, including OHSU, have as one of their aims for the grant to move medical education from a time-based to competency-based approach. There is no reason why every medical student has to spend exactly four years in school. Some may have backgrounds that allow them to accelerate their pace, which will be helpful as the need for physicians grows due to aging baby boomers and healthcare reform.

In a posting last year, I expressed concern about a time-based, in situ approach, which not only may limit the growth of capacity in the subspecialty, but also lock out a pathway to the profession for those who cannot disrupt work, families, or other aspects of their lives to uproot their lives to pursue a site-based clinical informatics subspecialty. OHSU has trained many physicians and others who have gone on to successful informatics careers using a mostly distance-based approach.

There are other problems that our response noted as well. A key one is the limitation of programs being administratively linked to the six specialties of Anesthesiology, Emergency Medicine, Medical Genetics, Pathology, Pediatrics, or Preventive Medicine. While this does not mean that physicians of any specialty will not be allowed to participate in a fellowship, we expressed concerns programs may be beholden to the affiliated specialty, either philosophically or fiscally, who may impose demands that could compromise the clinical informatics training experience. In addition, it may be difficult for trainees of specialties outside the affiliated one to pursue clinical work in their own specialty within the fellowship in a given institution that has a fellowship linked to a specific specialty.

We also expressed concern that clinical informatics fellows might not be able to practice their specialty as attending-level physicians and bill for their work. Being able to bill for practice in their primary specialty will be important not only for fellows’ maintaining clinical skills in their primary specialty but also for financial viability of the fellowship program.

We will eagerly await the ACGME response to ourselves and others who replied to their draft. In the meantime, planning will move forward for a clinical informatics subspecialty fellowship at OHSU. We also hope to work with other programs who seek help in providing educational content in their programs.

This post by William Hersh, MD, FACP, Professor and Chair, Department of Medical Informatics & Clinical Epidemiology, Oregon Health & Science University, appeared on his blog Informatics Professor, where he posts his thoughts on various topics related to biomedical and health informatics.

How regulations are hampering resident learning

Over the years, we have had regulation after regulation imposed on the patient note. We have had the addition of computer systems that work well for billing, but not as well for patient care. We have work hour requirements that lead to more handoffs, and now we demand that residents spend significant time preparing and delivering handoffs.

The distressing paucity of time that interns spend with their patients is not a new phenomenon: Back in 1989—before both work hour limitations and computers—a similar study showed that interns spent about 20% of their time with patients and about 40% in documentation (NEJM JW Gen Med Jun 30 1989). However, things clearly are moving in the wrong direction. These fascinating data ring completely true and should give program directors impetus to reevaluate critically the present routines of clinical training.

Osler taught us that we need to observe and communicate with patients at the bedside to really learn medicine. During training we need to spend sufficient time with our patients to understand disease and the progression of disease. When we sacrifice time with patients for charting, then we sacrifice our residents’ growth.

We see American Board of Internal Medicine pass rates decreasing.

Perhaps there is a link.

db is the nickname for Robert M. Centor, MD, FACP. db stands both for Dr. Bob and da boss. He is an academic general internist at the University of Alabama School of Medicine, and is the Associate Dean for the Huntsville Regional Medical Campus of UASOM. He also serves as a frequent ward attending at the Birmingham VA Hospital. This post originally appeared at his blog, db's Medical Rants.

QD: News Every Day--Primary care provider a primary influence on who gets a PSA screen after 75

Which primary care provider a man saw had a nearly 7-fold difference in who underwent a prostate-specific antigen screening after age 75, a study found.

Researchers reviewed Medicare Part A and B data for the year 2010 in the state of Texas to find primary care providers whose patient panels included at least 20 men who were 75 years or older and did not have a prior diagnosis of prostate cancer. There were nearly 2,000 providers with a total of more than 61,000 men.

Results appeared in a research letter by first author Elizabeth A Jaramillo, MD, ACP Resident/Fellow Member, and colleagues that appeared in the Oct. 16 issue of The Journal of the American Medical Association.

Overall, 28.8% of men underwent PSA screening ordered by their primary care providers (41.1% of all men underwent PSA screening). There were 474 primary care providers (24.2%) who had rates significantly greater than the mean, and they had a mean rate of 49.8% (95% CI, 48.8% to 50.8%). There were 314 primary care providers (16.0%) who had significantly lower rates, and they had a mean rate of 6.1% (95% CI, 5.9% to 6.3%).

27% of the variance in whether a man received a PSA screening was explained by which primary care provider he saw, compared to patient characteristics such as age or comorbidity, which explained only 3.7% of the variance—a nearly 7-fold difference, the researchers noted. And, there was a 10-fold difference in rates between the highest and lowest deciles of primary care providers.

While there was a 27% variance for PSA screening that was attributable to which primary care provider the man saw, there was a 10% variance for mammography depending on the provider, and a 9% variance for colorectal cancer screening by provider, the authors noted.

Wednesday, October 16, 2013

Doctor yoga

My wife went to a good yoga class the other day. (It was on Yom Kippur, actually, not the most typical yoga class.) I asked my wife what qualities make for a good yoga instructor, and this is what she came up with:• clarity• flow• pacing• explanation• kindness

I am biased, of course, but I think that this list summarizes the essential qualities of many different guides, including doctors, nurses, et al.

You can also interpret these terms in various ways. Clarity can be a quality of the practitioner themselves, someone who is transparent, easily read, or of their speech. Flow refers to the transition between parts of the visit, and pacing, to a perception of the patient (or yoga student) as much as to any objective rate. Explanation and kindness, of course, are less susceptible to interpretation.

According to that comparison, we should aim for someone to feel as refreshed and challenged coming out of the health care provider’s office as they do when leaving the yoga studio, meditation space, or house of prayer.

Zackary Berger, MD, ACP Member, is a primary care doctor and general internist in the Division of General Internal Medicine at Johns Hopkins. His research interests include doctor-patient communication, bioethics, and systematic reviews. He is also a poet, journalist and translator in Yiddish and English. This post originally appeared at his blog.

Doctors should evaluate physical activity habits as routinely as checking blood pressure and other risk factors for cardiovascular diseases, including physical activity types, frequency, duration and intensity at work, home and leisure, a major medical group announced.

The new statement includes a decision matrix to help providers select the most appropriate evaluation method for their patients, including low-cost or no-cost options, such as questionnaires that patients complete when they arrive for their appointment.

Options for evaluating physical activity vary by subjective measures (self-evaluations and recall questionnaires) compared to objective measures (measures of energy expenditure or physiological measures). The matrix also reviews testing equipment such as pedometers and accelerometers. The matrix then guides physicians to the best options for evaluating physical activity habits by the needs of the patient, the resources available to him or her, and the practical considerations of prescribing an evaluation.

An example case scenario works through implementation by imaging a group of internal medicine physicians in a group practice who have adopted the 2020 American Heart Association Impact Goals for ideal cardiovascular health, and the need to assess baseline activity levels of their patients. The scenario shows how the practice selects an evaluation that can be done quickly as part of a routine office visit and with limited resources.

Tuesday, October 15, 2013

CME medical course on malpractice draws hundreds of physicians

Some time ago, about 200 physicians met one evening for a conference. This is not newsworthy. Medical education is deeply engrained in our professional culture. Indeed, physicians are committed to lifelong learning and self-improvement. To stay current, we read several medical journals and professional communications, we attend lectures at our hospitals, we engage in on-line educational pursuits, we learn from colleagues and we travel to medical conferences. Conscientious physicians devote many hours to educational activities each week

On this night, however, we were not learning about new treatments for heart disease or diabetes. We were not learning about emerging strategies to diagnose cancer at a curable stage. There was no talk about new techniques to reduce hospital infections or other preventable complications. We were not even learning about “soft” subjects, such as medical ethics or doctor-patient communication issues.

We were together at the strong urging of our medical malpractice company who would discount our malpractice premium if we attended this evening soiree. So, 200 or so physicians were listening to lectures entitled, Avoiding Litigation Traps and Becoming Litigation Savvy. I’ve attended these annual seminars for several years.

The lectures are interesting and useful. In an indirect way, they serve to protect patients and improve medical quality. But, their true purpose is to minimize our legal vulnerability.

Is this how our patients want us to spend our educational time? Do they want us to learn about how to respond to sneaky questions at depositions? Do they want us to spend time learning about the legal discovery process? Do they want us to be focused on protecting our legal interests?

As busy as we physicians are, shouldn’t every minute available for our education be devoted to becoming better doctors?

This post by Michael Kirsch, MD, FACP, appeared at MD Whistleblower. Dr. Kirsch is a full time practicing physician and writer who addresses the joys and challenges of medical practice, including controversies in the doctor-patient relationship, medical ethics and measuring medical quality. When he's not writing, he's performing colonoscopies.

What is "overdiagnosis"?

I got an invitation in my e-mail a couple of days ago for a dinner presentation to the Central Oregon Medical Society given by H. Gilbert Welch, MD, on the subject of overdiagnosis. I was intrigued. A little less than a year ago Dr. Welch, an internist and professor at Dartmouth Medical School and Archie Bleyer, MD, a former pediatric oncologist and now a research professor at Oregon Health and Sciences University wrote a controversial article presenting compelling evidence that regular mammograms lead to death and disability related to aggressive treatment in many of the patients who were diagnosed with breast cancer but that it did not significantly improve survival.

Dr. Welch has been studying overdiagnosis for a couple of decades and has written two books, Should I Be Tested For Cancer?: Maybe Not and Here’s Why and Overdiagnosed: Making People Sick in the Pursuit of Health. I have peeked at the second one and found it to be well written, with a non-physician audience intended.

Overdiagnosis is defined as detecting disease in patients without symptoms which, if undetected and untreated, would lead to no harm. This is not a good thing. People who find that they have a disease often use more resources, get more testing and treatment with associated costs and side effects, and feel worse about their health. In the small picture, this is caused by increasingly sensitive screening tests, more strict definitions of normal and increased use of imaging procedures which see things we weren’t even looking for.

It has been pretty well established for breast cancer screening and for thyroid imaging, which detect low level cancers which probably would never progress, and for prostate cancer, for which in most cases the treatment is worse than the disease, and the disease is extremely common. It also appears to be true for kidney failure, which has been diagnosed more and more commonly in elderly people despite the fact that we know their kidney function normally declines with age. Overdiagnosis occurs when we remove colon polyps which had no malignant potential during excessively frequent colonoscopies and when we screen ancient and dying people for cancers which would never contribute to their inevitable demise.

Overdiagnosis is estimated to result in many, many billions of dollars of excess health care spending.

In the big picture, overdiagnosis is caused by the economics of our medical system: defining more people as sick increases use of medical care which keeps doctors and staff and the many industries that serve us and our patients in business. The patients who are overdiagnosed are also not very sick, or not sick at all, so they are easier to treat, mostly. It’s a win/win situation. Except that it isn’t.

Reducing our thresholds for defining disease is not entirely a bad thing, though. We have gradually reduced the blood sugar at which we diagnose a patient with diabetes. It turns out that slightly elevated blood sugars are nearly as predictive of bad outcomes as higher blood sugars. It has been my experience, as well, that patients who are told they have diabetes often immediately take seriously their needs for lifestyle changes, so they begin eating more healthily, exercising and losing weight which is undeniably good for them.

September 10-12, 2013 is the first ever conference on overdiagnosis at Dartmouth University, in which there will be talks about the extent of the problem and then discussion of ways to roll back excesses. Already there has been a conference on Selling Sickness which involved activists of many descriptions who came up with some resolutions to reduce “disease mongering.” These include improving research to determine what tests and treatments are actually effective and separating funding for this from parties whose economic interests would benefit from positive results. The American College of Physicians and many specialty organizations have gotten behind the “Choosing Wisely” campaign which targets tests, procedures and treatments which are without proven benefit, though they may be widely practiced.

When we, as doctors, think about it, we don’t want to be doing things that are of no particular benefit to our patients, even if it does give us job security. It makes us feel that our jobs are meaningless and it puts us at odds with the people we treat. We have been expanding our scope this way for so long, though, that it takes a while to change gears, and communication and education has to be excellent in order that we come to consensus. Many of us think we will be sued if somebody develops a condition that we could have screened for, even if that screening rationally would not have made a difference in their outcome. We need good solid support for curtailing our excesses.

Central Oregon is a long way away from where I am, a good 7-plus hour drive, and the talk is only a couple of hours long, so I think I’ll just read his book and read the articles that come out of the Dartmouth conference. If doctors who are well respected put their energy into this effort, good will come of it. I’m proud of us for trying.

Janice Boughton, MD, ACP Member, practiced in the Seattle area for four years and in rural Idaho for 17 years before deciding to take a few years off to see more places, learn more about medicine and increase her knowledge base and perspective by practicing hospital and primary care medicine as a locum tenens physician. She lives in Idaho when not traveling. Disturbed by various aspects of the practice of medicine that make no sense and concerned about the cost of providing health care to every American, she blogs at Why is American Health Care So Expensive?, where this post originally appeared.

Blog log

Members of the American College of
Physicians contribute posts from their own sites to
ACP Internistand ACP
Hospitalist. Contributors include:

Albert Fuchs,
MD
Albert Fuchs, MD, FACP, graduated from the
University of California, Los Angeles School of Medicine, where he
also did his internal medicine training. Certified by the American
Board of Internal Medicine, Dr. Fuchs spent three years as a
full-time faculty member at UCLA School of Medicine before opening
his private practice in Beverly Hills in 2000.

And Thus, It Begins
Amanda Xi, ACP Medical
Student Member, is a first-year medical student at the OUWB School
of Medicine, charter class of 2015, in Rochester, Mich., from which
she which chronicles her journey through medical training from day
1 of medical school.

Auscultation Ira S. Nash,
MD, FACP, is the senior vice president and executive director of the North Shore-LIJ
Medical Group, and a professor of Cardiology and Population Health at Hofstra North
Shore-LIJ School of Medicine. He is Board Certified in Internal Medicine and
Cardiovascular Diseases and was in the private practice of cardiology before joining the
full-time faculty of Massachusetts General Hospital.

Zackary Berger
Zackary Berger, MD, ACP Member, is a primary care doctor and
general internist in the Division of General Internal Medicine at
Johns Hopkins. His research interests include doctor-patient
communication, bioethics, and systematic reviews.

Controversies in Hospital
Infection Prevention
Run by three ACP
Fellows, this blog ponders vexing issues in infection prevention
and control, inside and outside the hospital. Daniel J Diekema, MD,
FACP, practices infectious diseases, clinical microbiology, and
hospital epidemiology in Iowa City, Iowa, splitting time between
seeing patients with infectious diseases, diagnosing infections in
the microbiology laboratory, and trying to prevent infections in
the hospital. Michael B. Edmond, MD, FACP, is a hospital
epidemiologist in Richmond, Va., with a focus on understanding why
infections occur in the hospital and ways to prevent these
infections, and sees patients in the inpatient and outpatient
settings. Eli N. Perencevich, MD, ACP Member, is an infectious
disease physician and epidemiologist in Iowa City, Iowa, who
studies methods to halt the spread of resistant bacteria in our
hospitals (including novel ways to get everyone to wash their
hands).

Suneel Dhand, MD, ACP Member Suneel Dhand, MD,
ACP Member, is a practicing physician in Massachusetts. He has published numerous
articles in clinical medicine, covering a wide range of specialty areas including;
pulmonology, cardiology, endocrinology, hematology, and infectious disease. He has also
authored chapters in the prestigious "5-Minute Clinical Consult" medical textbook. His
other clinical interests include quality improvement, hospital safety, hospital
utilization, and the use of technology in health care.

Dr. Mintz' Blog
Matthew Mintz, MD, FACP, has practiced internal medicine for more
than a decade and is an Associate Professor of Medicine at an
academic medical center on the East Coast. His time is split
between teaching medical students and residents, and caring for
patients.

FutureDocs
Vineet Arora, MD, FACP, is Associate Program Director for the
Internal Medicine Residency and Assistant Dean of Scholarship &
Discovery at the Pritzker School of Medicine for the University of
Chicago. Her education and research focus is on resident duty
hours, patient handoffs, medical professionalism, and quality of
hospital care. She is also an academic hospitalist.

Glass Hospital
John H. Schumann, MD, FACP, provides transparency on the workings
of medical practice and the complexities of hospital care,
illuminates the emotional and cognitive aspects of caregiving and
decision-making from the perspective of an active primary care
physician, and offers behind-the-scenes portraits of hospital
sanctums and the people who inhabit them.

Gut Check
Ryan Madanick, MD, ACP Member, is a gastroenterologist at the
University of North Carolina School of Medicine, and the Program
Director for the GI & Hepatology Fellowship Program. He
specializes in diseases of the esophagus, with a strong interest in
the diagnosis and treatment of patients who have
difficult-to-manage esophageal problems such as refractory GERD,
heartburn, and chest pain.

David Katz, MD
David L. Katz, MD, MPH, FACP, is an internationally renowned
authority on nutrition, weight management, and the prevention of
chronic disease, and an internationally recognized leader in
integrative medicine and patient-centered care.

Just Oncology
Richard Just, MD, ACP Member, has 36 years in clinical practice of
hematology and medical oncology. His blog is a joint publication
with Gregg Masters, MPH.

Medical Lessons
Elaine Schattner, MD, FACP, shares her ideas on education, ethics
in medicine, health care news and culture. Her views on medicine
are informed by her past experiences in caring for patients, as a
researcher in cancer immunology, and as a patient who's had breast
cancer.

Mired in MedEd
Alexander M.
Djuricich, MD, FACP, is the Associate Dean for Continuing Medical
Education (CME), and a Program Director in Medicine-Pediatrics at
the Indiana University School of Medicine in Indianapolis, where he
blogs about medical education.

More Musings
Rob Lamberts, MD, ACP Member, a med-peds and general practice
internist, returns with "volume 2" of his personal musings about
medicine, life, armadillos and Sasquatch at More Musings (of a
Distractible Kind).

Prescriptions
David M. Sack, MD, FACP, practices general gastroenterology at a
small community hospital in Connecticut. His blog is a series of
musings on medicine, medical care, the health care system and
medical ethics, in no particular order.

The Blog of Paul Sufka
Paul Sufka,
MD, ACP Member, is a board certified rheumatologist in St. Paul,
Minn. He was a chief resident in internal medicine with the
University of Minnesota and then completed his fellowship training
in rheumatology in June 2011 at the University of Minnesota
Department of Rheumatology. His interests include the use of
technology in medicine.

Technology in (Medical)
Education
Neil Mehta, MBBS, MS, FACP, is interested in use of technology in
education, social media and networking, practice management and
evidence-based medicine tools, personal information and knowledge
management.

Peter A. Lipson,
MD
Peter A. Lipson, MD, ACP Member, is a practicing internist and
teaching physician in Southeast Michigan. The blog, which has been
around in various forms since 2007, offers musings on the
intersection of science, medicine, and culture.

Why is American Health Care So Expensive?
Janice
Boughton, MD, FACP, practiced internal medicine for 20 years before
adopting a career in hospital and primary care medicine as a locum
tenens physician. She lives in Idaho when not traveling.

World's Best Site
Daniel Ginsberg, MD,
FACP, is an internal medicine physician who has avidly applied
computers to medicine since 1986, when he first wrote medically
oriented computer programs. He is in practice in Tacoma,
Washington.

Other
blogs of note:

American Journal of
Medicine
Also known as the Green Journal, the American Journal of Medicine
publishes original clinical articles of interest to physicians in
internal medicine and its subspecialities, both in academia and
community-based practice.

Interact MD
Michael Benjamin, MD, ACP member, doesn't accept industry money so
he can create an independent, clinician-reviewed space on the
Internet for physicians to report and comment on the medical news
of the day.

PLoS Blog
The Public Library of Science's open access materials include a
blog.

White Coat
Rants
One of the most popular anonymous blogs written by an emergency
room physician.

ACP Internist provides news and information for internists about the practice of medicine and reports on the policies, products and activities of ACP. All published material, which is covered by copyright, represents the views of the contributor and does not reflect the opinion of the American College of Physicians or any other institution unless clearly stated